- Cytiva (Marlborough, MA)
- …for Cytiva is responsible for supporting the Business and Customers in a global environment by providing quality documents and regulatory support in ongoing ... delivery.What you'll do:Support the Business and Customers in a global environment by providing quality documents and...in Biochemistry/Chemistry or related field3+ years of experience in GMP , quality , product management or a related… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Global Quality Lead , GMP , GDP Audit and Inspection - Pipeline Launch **Location:** Framingham, MA or Morristown, NJ **About the Job** We ... in Sanofi. + **Scope:** Manufacturing & Supply, Research & Development, Countries, Digital, Global Quality organizations in Sanofi. And third parties outside of… more
- Astellas Pharma (Westborough, MA)
- **Validation Lead , Quality Assurance** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are ... is headquartered in Massachusetts. Astellas is announcing a **Validation Lead , Quality Assurance** opportunity at their **Astellas...policies and procedures and industry best practices. The Validation Lead will ensure that all critical GMP … more
- Bristol Myers Squibb (Devens, MA)
- …External Manufacturing, Regulatory Affairs and Brand teams. The individual provides end-to-end global quality oversight of all cell therapy development programs ... for cell therapy commercial, clinical and development products. + Acts as lead Quality management reviewer/approver of regulatory submissions and responses to… more
- Sanofi Group (Framingham, MA)
- …view. **Scope** + Sanofi R&D Sites/ platforms, interactions with CMC, R&D Vaccines, Global Quality , Alliance Management, Global Regulatory Affairs, Clinical ... families. The purpose of this position is to provide quality technical management oversight of Sanofi sponsored GMP... manufacturing and testing of genomic medicines. Specifically, to lead the following activities: + Manage the quality… more
- Bristol Myers Squibb (Devens, MA)
- …as the Global Technical SME for Drug Product and Vector Validation. The lead will develop global technical standards for cell therapy validation and deploy ... providing SME assessment for proposed process life-cycle changes. The lead will serve as the Global Point...global cell therapy validation technical standards via the quality system. + Promote innovative and efficient approaches to… more
- Bristol Myers Squibb (Devens, MA)
- …BioPharma Operating Units, the Sr. Director, BI&T, Devens Digital Plant and Site BI&T Lead will be directly accountable to the US Biologics Leader and Devens Campus ... a standing member of the Devens Campus leadership team. **Key Responsibilities:** + Lead a matrixed organization composed of both site direct reports and groups of… more
- Sanofi Group (Framingham, MA)
- …and high- quality responses and support the development and promotion of Global Quality Documentation. + Supports the preparation, execution and closure of ... purposes, and ensuring accurate reporting to Operations Management and Global Quality . . **Core member of critical.... . **Core member of critical governance** + Sanofi's GMP GDP Quality Council to facilitate sharing… more
- Danaher Corporation (Marlborough, MA)
- …for Cytiva is responsible for supporting the Business and Customers in a global environment by providing quality documents and regulatory support in ongoing ... do: + Support the Business and Customers in a global environment by providing quality documents and...or related field + 3+ years of experience in GMP , quality , product management or a related… more
- Actalent (Framingham, MA)
- Job Description Lead and manage complex investigations related to deviations, non-conformances, and quality events across manufacturing, packaging, and ... root cause analyses and collaborate cross-functionally with Technical Operations, Manufacturing, Quality Control, and Regulatory Affairs to gather data and ensure… more
- Teleflex (Chelmsford, MA)
- …: Up to 10% **Requisition ID** :12097 **About Teleflex Incorporated** As a global provider of medical technologies, Teleflex is driven by our purpose to improve ... the health and quality of people's lives. Through our vision to become...of healthcare. For more information, please visit **teleflex.com** . ** Global Operations -** Global Operations is a… more
- Teleflex (Chelmsford, MA)
- …: Up to 10% **Requisition ID** :12166 **About Teleflex Incorporated** As a global provider of medical technologies, Teleflex is driven by our purpose to improve ... the health and quality of people's lives. Through our vision to become...of healthcare. For more information, please visit **teleflex.com** . ** Global Operations -** Global Operations is a… more
- Sanofi Group (Framingham, MA)
- …progression of multiple therapeutic candidates into the clinic. We are an innovative global healthcare company with one purpose: to chase the miracles of science to ... possible. Ready to get started? **Main Responsibilities** + Participate in and/or lead the development, qualification, and transfer of analytical methods in support… more
- Sanofi Group (Framingham, MA)
- …hope to patients and their families. You will be part of Sanofi Global Engineering's Manufacturing Systems & Automation department, embedded within project teams for ... region. This pivotal role offers a unique opportunity to influence the global manufacturing strategy through innovative solutions. You'll work with a dynamic team… more
- Sanofi Group (Framingham, MA)
- …with the manufacturing instruction set and current GMPs. We are an innovative global healthcare company with one purpose: to chase the miracles of science to ... revisions, and work order generation. + Fulfills role of lead trainer on numerous operations and is an area...SME. + Interacts with other support functions such as Quality Assurance, Quality Control, Manufacturing Engineering, MSIT,… more
- Sanofi Group (Framingham, MA)
- …diseases and bring hope to patients and their families. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve ... compliant, and efficient operation and maintenance of Clean Utility systems. + Lead the sites cross-functional sustainability program to deliver Sanofi's Planet Care… more
- Sanofi Group (Framingham, MA)
- …diseases and bring hope to patients and their families.** **We are an innovative global healthcare company with one purpose: to chase the miracles of science to ... is an area SME.** **Interacts with other support functions such as Quality Assurance, Quality Control, Manufacturing Engineering, MSIT, Validation, etc.**… more
- Olympus Corporation of the Americas (Westborough, MA)
- …. **Job Description** The Principal R&D Systems Engineer will lead or support Systems Engineering aspects on new product development ... collection of user needs/feedback on product requirements and concepts + Lead the requirements development and management process, incorporating risk management… more
- Bristol Myers Squibb (Devens, MA)
- …and provide Operations project information and activities status to Planning, Manufacturing, Quality Assurance / Operations, Global Supply and other associated ... and operational issues to prevent deviations and maintain a compliant environment. Lead and manage the development of corrective and preventative actions, deviation… more
- Bristol Myers Squibb (Devens, MA)
- …/ steering committee meetings for program team(s), prepares meeting materials with/for lead as requested, facilitates team meetings as needed, and documents actions ... senior leaders to drive decisions. + Monitor execution and quality to customer / stakeholder / sponsor standards. +...accomplishments and a proven track record. + Understanding of GMP and FDA regulatory requirements correlating to biologics. +… more
